Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Changkun Technology Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
317 daysmedian FDA review time
532 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | 2026-06-26 | 532 | 0 |
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD | Shenzhen Changkun Technology Co., Ltd. | 2026-05-06 | 266 | 0 |
| K231595 | Electric Breast Pump | Shenzhen Changkun Technology Co., Ltd. | 2023-10-26 | 147 | 0 |
| K221798 | Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. | 2023-05-04 | 317 | 0 |
| K193386 | Wrist Electronic Sphygmomanometer | Shenzhen Changkun Technology Co., Ltd. | 2021-01-27 | 418 | 0 |
| K193387 | Arm Electronic Sphygmomanometer | Shenzhen Changkun Technology Co., Ltd. | 2021-01-27 | 418 | 0 |
| K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1 | Shenzhen Changkun Technology Co., Ltd. | 2020-06-17 | 212 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda